2000 IU/ml χ 2 = P 0.05

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1 IFN-α 1b CHB α 1b IFN-α 1bNAs HBeAg CHB NAs12 36HBV DNA HBeAgCHB 77 IFN-α 1b4882 NAs 4812t χ 2 48 HBeAg 21.74% 20.29% HBeAg 5.63% 5.63%χ 2 = P 0.05 HBsAg7.25% 0%χ 2 = P 0.050% 4.22%χ 2 = P 0.05HBsAg 2000 IU/mlHBeAg 2000 IU/mlχ 2 = P 0.05 HBsAg HBeAgr = 0.606NAs HBeAg HBeAg IFN-α 1b NAs HBeAgCHB α 1b Effects of interferon alpha-1b in treating chronic hepatitis B patients who have poor response to nucleot(s)ide analogues JIN Rui 1, GUO Xin-hui 1, XU Zhi-qiang 2, JIAO Cheng-song 3, HU Guo-xin 4 (1.Beijing YouAn Hospital, Capital Medical University, Beijing ; 2.The 302 Military Hospital of China, Beijing , China; 3.Tongji Medical College, Huazhong University of Science & Technology, Wuhan , China; 4.Peking University Shenzhen Hospital, Shenzhen , China) Abstract: Objective To investigate the efficacy and safety of an extended course (48-week) of sequential interferon alpha-1b therapy for patients with HBeAg positive chronic hepatitis B (CHB) who have poor response to nucleot(s)ide analogue. Methods There were 159 HBeAg positive CHB patients who had completed a months of nucleot(s)ide analogues (NAs) monotherapy course, and who had achieved a virological response (HBV DNA 500 copies/ml) but without HBeAg seroconversion were enrolled. The patients were randomly assigned to receive IFN-α 1b plus NAs (experimental group, n = 77) or continue NAs monotherapy (control group, n = 82). Levels of biochemical, virological and serological were measured at baseline and at 12-week intervals throughout the treatment course. Inter-group differences were statistically evaluated by t-test or Chi-squared test. Results At treatment week 48, the experimental group showed significantly higher rate of HBeAg clearance (21.74% vs 7.04%, χ 2 = 7.738, P 0.05) and seroconversion DOI: /j.issn jinrui@public.bta.net.cn

2 (20.29% vs 7.04%, χ 2 = 6.709, P 0.05). The experimental group also showed higher rate of HBsAg seroconversion (7.25% vs 0, χ 2 = 5.335, P 0.05). The rates of HBV DNA relapse were 0 and 4.22%, but the difference did not reach statistical significance (χ 2 = 2.979, P 0.05). The patients who had higher baseline HBsAg ( 2000 IU/ml) showed lower HBeAg seroconversion than the patients who had lower HBsAg ( 2000 IU/ml), but the differences did not reach statistical significance (χ 2 = and 0.147, both P 0.05). Sequential plus IFN-α 1b could add the rated of HBeAg seroconversion at any time, while it may had relationship between the course of NAs and the rate of HBeAg seroconversion. Conclusions For patients with HBeAg-positive CHB who had unsatisfactory response to NAs monotherapy, plus IFN-α 1b has higher rate of seroconversion. Key words: Hepatitis B; Chronic; Interferon α1b; nucleotide(s)analogue HBV20 HBV3.5 [1] HBeAg HBeAg CHB [nucleot s ide analogue NAs] HBeAg NAs NAs [2-5] α 1b IFN-α 1bNAsNAs HBeAgCHB NAs NAs IFN-α 1b 150 μg/ NAs HBsAg HBeAg ADV LAM ETV HBV DNA 500/ml HBeAg ALT 2 ULN 1.3 HAV HCV HDV HEV HIV /L /L 1.4 HBV DNA HBVHBsAg-HBs HBeAg -HBe 3 HBV DNA HBV PCR HBV DNA Applied Biosystems /ml HBV HBsAg-HBs HBeAg-HBe-HBc RocheALT Bayer HBeAg 24 HBeAg 48 HBsAg HBV DNA 500/ml 1.6

3 SPSS 17.0 t χ 2 P HBVP HBeAg 24 48HBeAg P HBsAg % HBsAg HBsAgP HBV DNA HBsAg[% ] HBsAg HBsAg 5/ / / / χ P % HBV DNA χ 2 = P = HBsAg 2000 IU/ml48 HBeAg HBsAg 2000 IU/ml P HBsAg HBeAg y = x r = HBeAg 25 36P / x - s HBsAg IU/ml x - s HBeAg COI x - s n = 77 46/ n = 82 54/ χ 2 = t = t = t = P HBeAg[% ] HBeAg HBeAg HBeAg HBeAg 12/ / / / / / / / χ P HBsAgHBeAg [% ] HBeAg HBeAg HBsAg 2000 IU/ml 7/ / / / HBsAg 2000 IU/ml 8/ / / / χ P

4 NAsHBeAg [% ] HBeAg HBeAg / / / / / / / / χ P HBsAg HBeAg = 48 / 100% 100% ALT HBsAg7.18% 9300 HBV 2000 CHB [6] NAs HBeAg CHB HBV DNA HBeAg NAs [2-5] α [7] NAs Ning [8] 1 3HBV DNA HBeAg PEG-IFN-α 2a48 HBeAg IFN-α 1b NAs NAsHBeAg 48 HBeAg 21.74% 20.29% 5.63% 5.63%P 0.05NAsHBeAg CHB IFN-α 1b HBeAg Ning [8] Li [9] NAsIFN-α 1b HBsAg7.25% vs 0% P 0.05NAs IFN-α 1b HBV DNA P 0.05 NAs [7] HBsAg HBsAg HBeAg HBsAg HBeAgHBsAg

5 Ning [8] HBsAg HBeAg HBsAg HBeAg HBsAg HBeAg NAs IFN-α 1bHBeAg 12 24NAs % NAs483.57% 12 24IFN-α 1b % 25 36IFN-α 1b % NAs IFN-α 1b HBeAg20.52% IFN-α 1b HBeAg6.77% IFN-α 1bHBeAg NAs IFN-α 1b IFN-α 1b 3 HBeAg HBV DNA [10] NAs NAs [11] [12] HBeAg HBeAgCHB HBeAg [1] European Association for the study of the Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection[j]. J Hepatol,2012,57: [2] Dusheiko G. Treatment of HBeAg positive chronic hepatitis B: interferon or nucleoside analogues[j]. Liver Int,2013,33(Suppl 1): [3] Hui CK, Leung N, Yuen ST, et al. Natural history and disease progression in Chinese chronic hepatitis B patients in immunetolerant phase[j]. Hepatology,2007,46: [4] Yuen MF, Lai CL. Treatment of chronic hepatitis B: evolution over twodecades[j]. J Gsatroenterol Hepatol,2011,26 Suppl 1: [5] Hadziyannis SJ, Vassilopoulos D, Hadziyannis E. The natural course of chronic hepatitis B virus infection and its management[j]. Adv Pharmacol,2013,67: [6],. (2010)[J]. ( ),2011,3: [7] α( ). α( ) [J].,2013,21: [8] Ning Q, Han MF, Sun YT, et al. New treatment strategy: switching from long-term entecavir to peginterferon alga-2a induces HBeAg seroconversion/hbsag clearance in patients with HBeAg-positive chronic hepatitis B[J]. Hepatology,2012,56(Suppl 1):216A. [9] Li Q, Dong G, Yu J, et al. Adding peginterferon alfa-2a on nucleos(t) ide analogues therapy improves HBeAg seroconversion and HBsAg decline in HBeAg-positive chronic hepatitis B patients who have achieved virological responses[j]. J Hepatol,2013,58(Suppl 1):S307. [10],. (2010) [J].,2010,28: [11] European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B[J]. J Hepatol, 2009,50:

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